Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe (GRAVITY)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00525824
First received: September 5, 2007
Last updated: May 11, 2011
Last verified: May 2011

September 5, 2007
May 11, 2011
August 2007
September 2008   (final data collection date for primary outcome measure)
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment [ Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) ] [ Designated as safety issue: No ]
Percent change in LDL-C = (Combination treatment value - Baseline value)/Baseline value*100
The primary efficacy variable is the change in LDL-C relative to the baseline value. Change can be expressed as a percentage change. The primary variable is assessed after 6 wks of combination treatment
Complete list of historical versions of study NCT00525824 on ClinicalTrials.gov Archive Site
  • Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment [ Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) ] [ Designated as safety issue: No ]
    Percent change in HDL-C = (Combination treatment value - Baseline value)/Baseline value*100
  • Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment [ Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) ] [ Designated as safety issue: No ]
    Percent change in TC = (Combination treatment value - Baseline value)/Baseline value*100
  • Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment [ Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) ] [ Designated as safety issue: No ]
    Percent change in TG = (Combination treatment value - Baseline value)/Baseline value*100
  • Percent Change in Non-high-density Lipoprotein Cholesterol (nonHDL-C) After 6 Weeks Combination Treatment [ Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) ] [ Designated as safety issue: No ]
    Percent change in nonHDL-C = (Combination treatment value - Baseline value)/Baseline value*100
  • Percent Change in Apolipoprotein B (ApoB) After 6 Weeks Combination Treatment [ Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) ] [ Designated as safety issue: No ]
    Percent change in ApoB = (Combination treatment value - Baseline value)/Baseline value*100
  • Percent Change in Apolipoprotein A1 (ApoA-1) After 6 Weeks Combination Treatment [ Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) ] [ Designated as safety issue: No ]
    Percent change in ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100
  • Percent Change in TC/HDL-C After 6 Weeks Combination Treatment [ Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) ] [ Designated as safety issue: No ]
    Percent change in TC/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100
  • Percent Change in LDL-C/HDL-C After 6 Weeks Combination Treatment [ Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) ] [ Designated as safety issue: No ]
    Percent change in LDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100
  • Percent Change in Non-HDL-C/HDL-C After 6 Weeks Combination Treatment [ Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) ] [ Designated as safety issue: No ]
    Percent change in non-HDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100
  • Percent Change in ApoB/ApoA-1 After 6 Weeks Combination Treatment [ Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) ] [ Designated as safety issue: No ]
    Percent change in ApoB/ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100
  • Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) After 6 Weeks Combination Treatment [ Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) ] [ Designated as safety issue: No ]
    Percent change in hs-CRP = (Combination treatment value - Baseline value)/Baseline value*100
  • Percent Change in LDL-C After 6 Weeks Monotherapy [ Time Frame: Mean of Weeks 4 and 6 on monotherapy (Last observation carried forward) ] [ Designated as safety issue: No ]
    Percent change in LDL-C = (Monotherapy treatment value - Baseline value)/Baseline value*100
The secondary outcome variables include: o LDL-C, HDL-C, TC, TG, nonHDL-C, ApoB, ApoA-I, TC/HDL-C, LDLC/HDL-C, nonHDL-C/HDL-C and ApoB/ApoA-I, hs-CRP; and the corresponding measures of effects are the respective changes from baseline
Not Provided
Not Provided
 
12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe
A 12-week Open-label, Randomised, Parallel-group, Multicentre, Phase IIIb Study to Compare the Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe and Simvastatin in Patients With Hypercholesterolaemia and CHD

The purpose of this study is to determine whether treatment of Rosuvastatin (CRESTOR™) or Simvastatin given as monotherapy or given in combination with Ezetimibe, will lower the Low Density Lipoprotein Cholesterol (LDL-C) in patients with Hypercholesterolaemia and Coronary Heart Disease (CHD) or a CHD Risk Equivalent, Atherosclerosis or a 10-year CHD Risk of >20%

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypercholesterolemia
  • Coronary Heart Disease
  • Atherosclerosis
  • Drug: Rosuvastatin (Crestor)
    10mg and 20 mg
  • Drug: Ezetimibe
    10 mg
  • Drug: Simvastatin
    40mg and 80 mg
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1743
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with with hypercholesterolaemia and CHD or a CHD risk equivalent, clinical evidence of atherosclerosis or a Framingham 10-year CHD risk score of >20
  • Patients will need to sign an informed consent before any visit procedures can be performed, including procedures for the optional genetic research and biomarker studies.
  • Patients must be 18 years or older and will be asked to stop taking any current cholesterol-lowering medications. Dietary counselling will be provided which will include an overview of the Therapeutic Lifestyle Change (TLC) diet the patients will be asked to follow

Exclusion Criteria:

  • Use of lipid lowering drugs and other prohibited concomitant medications. History of statin-induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin, simvastatin and/or a history of hypersensitivity to any components of ezetimibe.
  • Patients considered to be unstable by their physician after the following events:

a myocardial infarction, recent episode of unstable angina, myocardial revascularisation [percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG) surgery or another revascularisation procedure] or a transient ischaemic attack (TIA) or stroke and patients awaiting a planned myocardial revascularisation

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Brazil,   Chile,   Colombia,   Lithuania,   Netherlands,   Peru,   Venezuela
 
NCT00525824
D356FC00003
Not Provided
Michael Cressman - Medical Science Director, AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Christie M Ballantyne, MD FACP FACC Centre for Cardiovascular Disease Prevention
Study Chair: Margareta Grind, MD PhD FFPM Medicine and Sciences AstraZeneca
AstraZeneca
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP